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January 11, 2026
Approximately 5 minutes
Performance Studies for In Vitro Diagnostic Medical Devices in Switzerland – Swissmedic Requirements
Performance Studies for In Vitro Diagnostic Medical Devices in Switzerland – Swissmedic Requirements
Legal Basis and Scope
Performance studies for in vitro diagnostic medical devices are regulated under the Medical Devices Ordinance (MedDO), the Clinical Trials Ordinance for Medical Devices (ClinO-MD), and the Human Research Act (HRA). These rules align with the EU IVDR 2017/746 while incorporating Swiss-specific requirements. Performance studies aim to generate data on analytical and clinical performance, safety, and intended use of IVDs, supporting conformity assessment or post-market activities. All studies involving human samples or data fall under this framework, with risk-based oversight. Leistungsstudien - Swissmedic
Classification and Authorisation Levels
- High-risk performance studies (IVDs for high individual/public health risk, companion diagnostics, blood/tissue screening) require Swissmedic authorisation plus cantonal ethics committee approval.
- Lower-risk studies (most other IVDs) require ethics committee approval and notification to Swissmedic.
- Studies using leftover samples without additional intervention may qualify for simplified procedures or exemptions.
Applications must include the performance study plan, investigator brochure, risk assessment, participant information/consent forms, laboratory methods, and evidence of manufacturing quality.
Good Clinical Practice and Standards
Performance studies must comply with ISO 20916 (Good Clinical Practice for IVD performance studies) and Swiss HRA ethical principles. Key requirements include:
- Independent ethics committee review.
- Informed consent (or waiver for anonymised leftover samples under strict conditions).
- Protection of participant rights, safety, and data privacy (FADP compliance).
- Adequate insurance and compensation arrangements.
Swissmedic may conduct inspections and request corrective actions for non-compliance.
Notification, Reporting, and Safety
- Serious adverse events and device deficiencies must be reported immediately to Swissmedic and the ethics committee.
- Annual progress/safety reports are mandatory for authorised studies.
- End-of-study reports including final results must be submitted; publication of results is encouraged.
Special Cases and Transitional Rules
- IVDs with CE marking used within intended purpose in performance studies may follow notification procedures.
- Combined drug-IVD studies require coordination with Swissmedic's medicinal products division.
- Transitional provisions apply to studies started under previous regulations.
Practical Guidance
Swissmedic provides application templates, checklists, detailed guidance on ISO 20916 implementation, and a dedicated contact point. Early consultation is recommended for complex studies or those involving vulnerable populations. The authority publishes annual statistics and summaries of authorised performance studies.
This framework ensures high scientific and ethical standards for IVD performance studies in Switzerland, supporting reliable data generation for safe and effective diagnostic tools. Complete requirements, forms, timelines, and resources are available on the Swissmedic performance studies page. Leistungsstudien - Swissmedic
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